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A New Concept on Quality Marker for Quality Assessment and Process Control of Chinese Medicines

Chinese Herbal Medicines 2017年第1期9卷 3-13页

作者： Chang-xiao Liu Yi-yu Cheng De-an Guo Tie-jun Zhang Ya-zhuo Li Wen-bin Hou Lu-qi Huang Hai-yu Xu Research Center for New Drug Evaluation Tianjin Institute of Pharmaceutical Research Tianjin 300193 China Institute of Pharmaceutical Information Zhejiang University Hangzhou 310058 China Shanghai Institute of Materia Medica Chinese Academy of Sciences Shanghai 201203 China Research Center for Modern Chinese Medicines Tianjin Institute of Pharmaceutical Research Tianjin 300193 China Institute of Chinese Materia Medica China Academy of Chinese Medical Sciences Beijing 100700 China

Chinese medicine （CM） is the most typical conventional therapy compared with any other traditional or alternative medicine systems. The active components of CMs are either primary or secondary metabolites generated by metabolic and biosynthetic enzymes in plants, protecting the plants from environmental stress. The characteristics of these metabolites are diverse, complicated and unique. In this paper, current approaches for quality assessment were extensively reviewed, a new concept of quality marker （Q-marker） was then proposed for CM quality assessment. Additionally, definition of the Q-marker, as well as the relevant methods, were discussed, on the basis of the biosynthetic pathways of secondary metabolites and source of biological active components. Study design of Q-marker is complex system for quality assessment and production process control of CM products with transitivity and traceability. Therefore, the system with characteristics of transmission and traceability is expected to be established for regulation of quality. Upon the concept which the transitivity and traceability in the quality assessment and production process control covered the entire process, such as raw materials, decoction slices, processing, extraction and production can be further enhanced. The transitivity and traceability will inevitably require close attention to ＂who, what, where, when, and why＂ details at each stage of Q-markers of CM production form raw materials to patent product. The establishing quality standards are enablers of many and various transitivity and traceability solutions, not a solution in them. It means that the transitivity and traceability system is readily link between products and across borders in quality. According to the thinking mode and methods of investigation on quality assessment of CM product, we focus on the entire process, in terms of safety and effectiveness and quality control. The standard preparation of CM or CM decoction is not only the basis

关键词： Chinese medicine formulation medicinal resource quality administration quality marker quality standard quantitative analysis secondary metabolites

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